Escitalopram Treatment of Night Eating Syndrome
Primary Purpose
Night Eating Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Night Eating Syndrome focused on measuring Eating disorder
Eligibility Criteria
Inclusion Criteria:
- Age 18-70 years
- Presence of NES
- BMI 25-50
Exclusion Criteria:
- History of schizophrenia or other psychoses
- History of bipolar disorder, anorexia nervosa, bulimia, binge eating disorder
- Current major depressive disorder
- Suicidal ideation
- Psychotropic drugs in the past month
- Drugs or herbal remedies that significantly affect body weight, current participation in a weight loss program, currently following a specialized diet (e.g., Atkins, Zone, etc)
- Lack of benefit with SSRI treatment for NES
- Serious or unstable medical illness
- Allergy or hypersensitivity to escitalopram
- Pregnant, breast-feeding, or planning pregnancy in the next six months.
Sites / Locations
- Saint Louis University
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Escitalopram
Placebo
Outcomes
Primary Outcome Measures
Night Eating Questionnaire
The Night Eating Questionnaire (NEQ) is a 14-item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hyperphagia, morning anorexia, and mood/sleep. Scores range from 0-56, with higher scores indicative of greater severity. The NEQ has an acceptable internal consistency reliability (.70). A cut-score of 25 has been shown to yield a positive predictive value of .62.
Secondary Outcome Measures
Change in Beck Depression Inventory II (BDI-II) Score
The BDI-II is a 21-item self-report questionnaire designed to measure cognitive, somatic, and behavioral aspects of depression. Scores range from 0 to 63, with higher scores indicating a higher level of depressive symptoms.
Change in Coping Inventory for Stressful Situations (CISS)
TASK = task-oriented coping; EMOT = emotion-oriented coping; AVD = avoidance-focused coping; Avoidance-focused coping may be divided into two subtypes: DIS = distraction-oriented coping; SOC = social diversion-oriented coping. CISS is a 48 item self-report measure used to measure responses to stressful situations rated for frequency on a 5 point Likert scales ranging from1, not at all to 5, very much. This measure assesses three coping styles: Task-Oriented, Emotion-Oriented, and two types of Avoidance-Oriented coping (Social Diversion and Distraction). There are 16 items on each of the primary scales (task, emotion, avoidance) and 5 on social diversion and 8 on distraction. Scores are summed for each subscale and then converted to gender-corrected t-scores with a mean of 50 and a standard deviation of 10. T-scores on the CISS range from a low of 25 (1st percentile) to 75 (99th percentile). Higher scores indicate more adaptive levels of coping.
Change in Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.
Change in Three Factor Eating Questionnaire (TFEQ)
The TFEQ (also known as the Eating Inventory) measures dimensions of eating behavior including cognitive restraint of eating, disinhibition, and hunger using a combination of dichotomous questions, 4-point likert scales, and one 5-point likert scale. Restraint is comprised of the responses to 21 questions with possible scores ranging from 0 to 21 (Low scores for all scales indicate an uninhibited eating behavior.). Disinhibition is comprised of the responses to 16 questions with possible scores ranging from 0 to 16 (High scores indicate an uninhibited eating behavior strongly depending on external cues). Hunger is comprised of the responses to 14 questions with possible scores ranging from 0 to 14 ( Low scores indicate an eating behavior strongly depending on feelings of hunger.).
RES = Restraint Subscale; DIS = Disinhibition Subscale; HUN = Hunger Subscale
Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2
The CGI-I scale is a clinician rating of overall therapeutic effect ranging from 1 (very much improved) to 7 (very much worse) since commencing treatment.
Change in Lipid Panel
Change in Beck Anxiety Inventory (BAI) Score
The Beck Anxiety Inventory (BAI) is a 21-item self-report measure of anxiety. Scores range from 0 to 63, with higher scores indicative of higher levels of anxiety.
Change in Glucose
Change in Weight
Number of Participants Who no Longer Meet the NESHI Criteria
The Night Eating Syndrome History and Inventory (NESHI) is an unpublished, semistructured interview used to confirm a diagnosis of NES. It assesses a typical 24-hour food intake, including a recall of all meals and snacks, and sleeping patterns. Based on the recall of all meals and snacks, the interviewer judged whether ≥25% of the daily caloric intake was eaten after the evening meal and how often nocturnal ingestions occurred. The NEQ items were reviewed and informed by the dietary recall during the interview, and a new total score was tallied. A final score of ≥25 for the NEQ items, as reviewed during the NESHI, was used as the criterion for NES.
Number of Participants Who Had a 50% Reduction in NEQ Scores
The Night Eating Questionnaire (NEQ) is a 14 item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hypcrphagia, morning anorexia, and mood/slccp. Scores range from 0 to 56, with higher scores indicative of greater severity.
Full Information
NCT ID
NCT00636649
First Posted
February 3, 2008
Last Updated
May 23, 2016
Sponsor
Duke University
Collaborators
St. Louis University
1. Study Identification
Unique Protocol Identification Number
NCT00636649
Brief Title
Escitalopram Treatment of Night Eating Syndrome
Official Title
Escitalopram Treatment of Night Eating Syndrome: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
St. Louis University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Night-Eating Syndrome (NES) is an eating disorder characterised by excessive eating at night, sleep disturbance and morning anorexia. This 12-week study examines the effect of escitalopram on symptoms of NES.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Night Eating Syndrome
Keywords
Eating disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Escitalopram
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
10-20 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Night Eating Questionnaire
Description
The Night Eating Questionnaire (NEQ) is a 14-item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hyperphagia, morning anorexia, and mood/sleep. Scores range from 0-56, with higher scores indicative of greater severity. The NEQ has an acceptable internal consistency reliability (.70). A cut-score of 25 has been shown to yield a positive predictive value of .62.
Time Frame
baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change in Beck Depression Inventory II (BDI-II) Score
Description
The BDI-II is a 21-item self-report questionnaire designed to measure cognitive, somatic, and behavioral aspects of depression. Scores range from 0 to 63, with higher scores indicating a higher level of depressive symptoms.
Time Frame
Baseline, 12 weeks
Title
Change in Coping Inventory for Stressful Situations (CISS)
Description
TASK = task-oriented coping; EMOT = emotion-oriented coping; AVD = avoidance-focused coping; Avoidance-focused coping may be divided into two subtypes: DIS = distraction-oriented coping; SOC = social diversion-oriented coping. CISS is a 48 item self-report measure used to measure responses to stressful situations rated for frequency on a 5 point Likert scales ranging from1, not at all to 5, very much. This measure assesses three coping styles: Task-Oriented, Emotion-Oriented, and two types of Avoidance-Oriented coping (Social Diversion and Distraction). There are 16 items on each of the primary scales (task, emotion, avoidance) and 5 on social diversion and 8 on distraction. Scores are summed for each subscale and then converted to gender-corrected t-scores with a mean of 50 and a standard deviation of 10. T-scores on the CISS range from a low of 25 (1st percentile) to 75 (99th percentile). Higher scores indicate more adaptive levels of coping.
Time Frame
Baseline, 12 weeks
Title
Change in Perceived Stress Scale (PSS)
Description
The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress.
Time Frame
12 weeks
Title
Change in Three Factor Eating Questionnaire (TFEQ)
Description
The TFEQ (also known as the Eating Inventory) measures dimensions of eating behavior including cognitive restraint of eating, disinhibition, and hunger using a combination of dichotomous questions, 4-point likert scales, and one 5-point likert scale. Restraint is comprised of the responses to 21 questions with possible scores ranging from 0 to 21 (Low scores for all scales indicate an uninhibited eating behavior.). Disinhibition is comprised of the responses to 16 questions with possible scores ranging from 0 to 16 (High scores indicate an uninhibited eating behavior strongly depending on external cues). Hunger is comprised of the responses to 14 questions with possible scores ranging from 0 to 14 ( Low scores indicate an eating behavior strongly depending on feelings of hunger.).
RES = Restraint Subscale; DIS = Disinhibition Subscale; HUN = Hunger Subscale
Time Frame
Baseline, 12 weeks
Title
Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2
Description
The CGI-I scale is a clinician rating of overall therapeutic effect ranging from 1 (very much improved) to 7 (very much worse) since commencing treatment.
Time Frame
12 weeks
Title
Change in Lipid Panel
Time Frame
Baseline,12 weeks
Title
Change in Beck Anxiety Inventory (BAI) Score
Description
The Beck Anxiety Inventory (BAI) is a 21-item self-report measure of anxiety. Scores range from 0 to 63, with higher scores indicative of higher levels of anxiety.
Time Frame
Baseline, 12 weeks
Title
Change in Glucose
Time Frame
Baseline, 12 Week
Title
Change in Weight
Time Frame
Baseline, 12 week
Title
Number of Participants Who no Longer Meet the NESHI Criteria
Description
The Night Eating Syndrome History and Inventory (NESHI) is an unpublished, semistructured interview used to confirm a diagnosis of NES. It assesses a typical 24-hour food intake, including a recall of all meals and snacks, and sleeping patterns. Based on the recall of all meals and snacks, the interviewer judged whether ≥25% of the daily caloric intake was eaten after the evening meal and how often nocturnal ingestions occurred. The NEQ items were reviewed and informed by the dietary recall during the interview, and a new total score was tallied. A final score of ≥25 for the NEQ items, as reviewed during the NESHI, was used as the criterion for NES.
Time Frame
Week 12
Title
Number of Participants Who Had a 50% Reduction in NEQ Scores
Description
The Night Eating Questionnaire (NEQ) is a 14 item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hypcrphagia, morning anorexia, and mood/slccp. Scores range from 0 to 56, with higher scores indicative of greater severity.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-70 years
Presence of NES
BMI 25-50
Exclusion Criteria:
History of schizophrenia or other psychoses
History of bipolar disorder, anorexia nervosa, bulimia, binge eating disorder
Current major depressive disorder
Suicidal ideation
Psychotropic drugs in the past month
Drugs or herbal remedies that significantly affect body weight, current participation in a weight loss program, currently following a specialized diet (e.g., Atkins, Zone, etc)
Lack of benefit with SSRI treatment for NES
Serious or unstable medical illness
Allergy or hypersensitivity to escitalopram
Pregnant, breast-feeding, or planning pregnancy in the next six months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kishore Gadde, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63103
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22544016
Citation
Vander Wal JS, Gang CH, Griffing GT, Gadde KM. Escitalopram for treatment of night eating syndrome: a 12-week, randomized, placebo-controlled trial. J Clin Psychopharmacol. 2012 Jun;32(3):341-5. doi: 10.1097/JCP.0b013e318254239b.
Results Reference
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Escitalopram Treatment of Night Eating Syndrome
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